510(k) K101046 ยท DTX Gas Control Unit, Cardiopulmonary Bypass
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 9, 2010 |
| Received | Apr 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.